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Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006265
First Posted: November 2, 2009
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Actelion
  Purpose
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

Condition Intervention Phase
Multiple Sclerosis Drug: ACT-128800 Dose 1 Drug: Placebo Drug: ACT-128800 Dose 2 Drug: ACT-128800 Dose 3 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Cumulative number of new gadolinium-enhancing lesions per patient recorded on four-weekly T1-weighted magnetic resonance imaging (MRI) scans [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Annualized confirmed relapse rate [ Time Frame: 24 weeks ]
  • Time to first confirmed relapse [ Time Frame: 24 weeks ]

Enrollment: 464
Study Start Date: October 1, 2009
Study Completion Date: July 1, 2011
Primary Completion Date: June 1, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT-128800 Dose 1
ACT-128800 Dose 1
Drug: ACT-128800 Dose 1
ACT-128800 (Dose 1) administered orally once daily
Experimental: ACT-128800 Dose 2
ACT-128800 Dose 2
Drug: ACT-128800 Dose 2
ACT-128800 (Dose 2) administered orally once daily
Experimental: ACT-128800 Dose 3
ACT-128800 Dose 3
Drug: ACT-128800 Dose 3
ACT-128800 (Dose 3) administered orally once daily
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo administered orally once daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult males and females
  • Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
  • Signed inform consent prior to initiation of any study-mandated procedure.

Exclusion Criteria:

  • A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
  • Patients currently treated for an autoimmune disorder other than MS.
  • Contraindications for MRI.
  • Ongoing bacterial, viral, or fungal infection.
  • History or presence of malignancy.

Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006265


  Show 115 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Actelion Pharmaceuticals Actelion
  More Information

Publications:
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01006265     History of Changes
Other Study ID Numbers: AC-058B201
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: April 4, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases